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**Job Function: **
Product Safety
**Job Sub Function: **
Pharmacovigilance
Job Category:
Scientific/Technology
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
＜Position Summary＞
From investigational phase through post-marketed phase, take full accountability to provide functional expertise, leadership, support, and assistance to cross-functional teams and managements to achieve functional goals and objectives, while ensuring the local Pharmacovigilance (PV) system is managed in compliance with applicable regulations and company policies/procedures.
Implement safety risk management related activities from investigational phase through post-marketed phase, including the preparation and implementation of risk management activities (e.g., aggregate reporting and safety measures) for the J&J Innovative Medicine Japan portfolio and products—such as risk assessment and risk minimization planning within responsible therapeutic area—by liaising with J-PSC members and Safety Control Manager as appropriate to facilitate compliant, high-quality, timely and efficient benefit-risk management.
Works under general supervision and contributes to activities related to the local PV system.
Individual contributor that performs more complex assignments and contributes to projects and processes within own area of responsibility.
Applies general knowledge and understanding of principles and practices to address problems.
＜Responsibilities＞
Take full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting under GCP and GVP and all activities related to clinical studies.
Ensure the local PV system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels, and in accordance with PV agreements with third-party business partners, as applicable.
Lead and facilitate J-PSC meetings in collaboration with internal key stakeholders.
Communicate closely with global stakeholders on responsible products/compounds.
Join NPI and other related committees with license partner companies as a representative for J-PSC of responsible products/compounds, proactively lead safety risk management discussions, and take necessary actions from early clinical development through post-marketed phase.
Lead and contribute to the prevention and rapid resolution of local safety risk management related issues, including timely stakeholder management (internal and external) of responsible products/compounds.
In all discussions including planning of safety measures and J-RMP, scientifically and logically drive alignment toward the final landing; conduct layer-based stakeholder management based on the discussion; and facilitate the members to discuss from the same perspective.
For aggregate reporting, review (and translate if applicable), prepare, submit, and track required local aggregate reports.
Ensure awareness of new/changes in local PV regulations; evaluate impact on local/global processes; notify appropriate local, regional and global groups; and support implementation of global PV procedural documents and local regulatory requirements, as applicable.
Provide input to requests for information supporting the development of LMS-wide processes, systems, and policies.
Engage in local industry associations/policy shaping initiatives based on One J&J Voice, as applicable.
Support internal discussion and local implementation of Risk Management Plans (RMPs)/addendums, including additional risk minimization activities and interactions/negotiation with local Health Authorities, as applicable.
Support implementation of Company Core Data Sheet (CCDS) updates into local labels/materials (e.g., SmPC, patient leaflet) as applicable.
Plan and monitor budgets and control expenditures for responsible products/compounds in collaboration with supervisors.
Contribute to continuous process improvements from an advanced safety management point of view by utilizing latest technologies while enhancing sustainable efficiency.
Understand and comply with relevant regulations such as PMD Act., GCP and GVP, and ensure compliance within own responsibility.
Ensure compliance with own training curriculum and required PV/quality training.
＜Requirements＞
- Experience/Knowledge
8-year or more experiences in pharmaceutical industries are generally recommended.
Excellent verbal and written communication skills; ability to effectively communicate and negotiate with internal and external stakeholders (including Health Authorities) and to establish and maintain relationships.
Excellent analytical skills to identify gaps/root causes and propose practical solutions; strong computer proficiency (e.g., MS Office) and proficiency in global and local SOPs/procedural documents.
Must be able to work independently with minimum supervision while meeting tight deadlines; fluency in Japanese and English is required.
- Skills/Capabilities
Must have strong leadership including decision making, management, negotiation, and stakeholder management and communication skills necessary.
Ability/competency to show contentious proposals to responsible teams and groups.
English communication skill (TOEIC 800 point and above), verbal, writing, presenting and facilitating.
- Qualification/Certificate
BA degree in a biological or medically related field is preferred.
＜For Internal Applicants＞
Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Clinical Operations, Coaching, Collaborating, Cross-Functional Collaboration, Detail-Oriented, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy